BENICAR HCT Drug Patent Profile
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When do Benicar Hct patents expire, and when can generic versions of Benicar Hct launch?
Benicar Hct is a drug marketed by Cosette and is included in one NDA.
The generic ingredient in BENICAR HCT is hydrochlorothiazide; olmesartan medoxomil. There are thirty-two drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; olmesartan medoxomil profile page.
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Questions you can ask:
- What is the 5 year forecast for BENICAR HCT?
- What are the global sales for BENICAR HCT?
- What is Average Wholesale Price for BENICAR HCT?
Summary for BENICAR HCT
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 94 |
Clinical Trials: | 17 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for BENICAR HCT |
Drug Sales Revenues: | Drug sales revenues for BENICAR HCT |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BENICAR HCT |
What excipients (inactive ingredients) are in BENICAR HCT? | BENICAR HCT excipients list |
DailyMed Link: | BENICAR HCT at DailyMed |
![BENICAR HCT drug patent expirations Drug patent expirations by year for BENICAR HCT](/p/graph/s/t/BENICAR_HCT-patent-expirations.png)
![Drug Prices for BENICAR HCT](/p/graph/drug-price/BENICAR+HCT.png)
See drug prices for BENICAR HCT
![Drug Sales Revenue Trends for BENICAR HCT](/p/graph/drug-sales-revenues/BENICAR+HCT.png)
Recent Clinical Trials for BENICAR HCT
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
EMS | Phase 3 |
Daiichi Sankyo Co., Ltd. | N/A |
Chinese PLA General Hospital | Phase 4 |
Pharmacology for BENICAR HCT
Drug Class | Angiotensin 2 Receptor Blocker Thiazide Diuretic |
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Physiological Effect | Increased Diuresis |
Paragraph IV (Patent) Challenges for BENICAR HCT
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
BENICAR HCT | Tablets | hydrochlorothiazide; olmesartan medoxomil | 20 mg/12.5 mg | 021532 | 1 | 2007-05-11 |
BENICAR HCT | Tablets | hydrochlorothiazide; olmesartan medoxomil | 40 mg/12.5 mg and 40 mg/25 mg | 021532 | 1 | 2007-02-15 |
US Patents and Regulatory Information for BENICAR HCT
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-002 | Jun 5, 2003 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-003 | Jun 5, 2003 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-005 | Jun 5, 2003 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for BENICAR HCT
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-005 | Jun 5, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-005 | Jun 5, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-002 | Jun 5, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-003 | Jun 5, 2003 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BENICAR HCT
See the table below for patents covering BENICAR HCT around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Russian Federation | 2128173 | DERIVATIVES OF 1-BIPHENYLMETHYLIMIDAZOLE, A METHOD OF THEIR SYNTHESIS AND A PHARMACEUTICAL COMPOSITION FOR TREATMENT AND PROPHYLAXIS OF PATIENTS WITH HYPERTENSION | ⤷ Sign Up |
Spain | 2155827 | ⤷ Sign Up | |
Austria | 200777 | ⤷ Sign Up | |
South Korea | 20030096235 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BENICAR HCT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0502314 | SPC/GB02/037 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419 |
0503785 | C00503785/02 | Switzerland | ⤷ Sign Up | FORMER OWNER: SANKYO COMPANY LIMITED, JP |
0503785 | CA 2011 00026 | Denmark | ⤷ Sign Up | PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216 |
0503785 | 91056 | Luxembourg | ⤷ Sign Up | 91056, EXPIRES: 20170221 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |